Responsibilities
Zent2U is a pharmaceutical B2B company focused on delivering high-quality medicines and therapeutic solutions to our partners across the globe. Our commitment to excellence, safety, and innovation is at the core of every product we deliver. About the role As a Quality Assurance Specialist at Zent2U, you will do quality lifecycle management for dedicated product portfolio, support launch process from QA perspective and coordinate QA topics between manufacturing sites and customers. You will be integral in upholding the company's reputation for delivering pharmaceutical products that exceed both industry standards and client expectations. You will lead quality assurance initiatives, streamline processes, and act as a beacon of expertise in all matters related to product quality. Key Responsibilities Operational and coordination skills: Operational and coordination for dedicated B2B product portfolio, for clinical trials and other exceptional flows cases - Deviation execution and coordination, Complaint execution, Risk coordination, QA agreement creation and coordination, PQRs and Stability support, Portfolio compliance revision, CAPA execution, Out of stock participation, Product database maintenance (QF), CoA/CoC support, QA support of launches and transfers execution. Change Control Management: Full responsibility for B2B Change Controls to evaluate, authorize, implement and record changes in a controlled manner including providing expert evaluation and communication with B2B customers to obtain all necessary permits for Change Control approval and implementation. GMP: QA GMP, GDP, MDR, HACCP Legislation and process trainings, personal file maintenance. Conducting a quarter review of performed activities (including evaluation of achieving and progress of key indicators). Other tasks: The employee will perform other tasks under the direction of Manager within the agreed type of work and support customer requests. Other responsibilities HSE: Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System. PHARMACOVIGILANCE: All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety inform. Communication & Working Relationship: both internal: All B2B functions, All Zentiva departments, Zentiva manufacturing sites and Zentiva Affiliates and external: Customer and Third Party/CMO. Qualifications & Experience University Degree in Pharmacy, Chemistry, or related field. Advanced degree preferred. 2-3 years of experience in the pharmaceutical industry, with a proven track record in quality assurance roles. Extensive knowledge of GMP, FDA, EMA, and other relevant international regulatory standards. Strong analytical, problem-solving, and organizational skills. Excellent written and verbal English communication skills. Proactive attitude and self-reliance. What do we offer Competitive salary; Additional benefits package; Hybrid mode of work; International working environment and a passionate team of professionals; Continuous Learning & Development opportunities. Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4 700 people and a network of production sites - including flagship sites in Prague, Bucharest, and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better support people’s daily healthcare needs. At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high-quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators, and governments to provide the everyday solutions that we all depend on.
